Sterile Operations Manager

Audubon, PA

At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.

Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!

Position Summary:

The Sterile Operations Manager will be responsible for supporting the scale-up and optimization of current and new manufacturing processes within the Sterile Manufacturing Group.  This person will be overseeing the development, qualification, validation, and documentation of manufacturing systems, equipment, and processes for new products being transferred from product development.  The Sterile Operations Manager will also be responsible for the daily oversight of Sterile Processing, Inventory and Planning management, process engineering and optimizing current manufacturing procedures. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced environment as well as being able to work independently with little to no supervision. The candidate must be enthusiastic, positive, even tempered, and possess strong skills in areas of dependability, interpersonal relationships, communication, organization, and flexibility. Familiarity with ISO requirements, FDA Regulations, and cGMP’s a plus.

The responsibilities of the position include, but are not limited to, the following: 

  • Maintaining daily oversite of established major KPIs and reporting
  • Providing support and guidance to Production and Inventory/Planning supervisors 
  • Overseeing production planning and execution
  • Interfacing with Purchasing team as needed to ensure product availability for production
  • Acting as the liaison between product development and Operations
  • Interfacing with Quality Assurance/Quality Control to assure products and processes comply with all required regulations
  • Evaluating and optimizing existing manufacturing processes
  • Overseeing process engineering activities, including but not limited to, IQ/OQ/PQ’s on new manufacturing equipment
  • Demonstrating effective writing skills for drafting SOP’s, Oper. & Maint. Procedures, protocols, reports, and other manufacturing related documentation
  • Evaluating current production capabilities and recommends improvements
  • Demonstrating and applying a thorough understanding of engineering and scientific principles related to medical device manufacturing
  • Maintaining up to date knowledge with respect to relevant state-of-the-art technology, equipment, and/or systems
  • Maintaining laboratory equipment to document process development and optimization
  • Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
  • Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

In order to be qualified for this role, you must possess the following:

  • 1-2 years’ experience with mechanical, electrical, and chemical systems and equipment preferably in medical device 
  • Bachelor’s Degree in mechanical, electrical, chemical, or biomedical engineering
  • Knowledge of polymer processing, ceramic processing, and/or tissue processing
  • Possesses strong hands-on ability with good mechanical aptitude
  • Working knowledge of Windows, Microsoft Office, E-mail, and Pro-Engineer
  • Must be a team player capable of working in a deadline dictated environment
  • Excellent verbal and written communication skills

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

JOB CODE: 1001085